Principal Quality Engineer
Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.
Principal Duties and Responsibilities
Evaluates process methods and equipment to meet performance and quality requirements.
Establishes quality plans for equipment and processes for general and specific product performance needs.
Monitors performance of processes to standards.
Applies ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers; Works with suppliers on new product introduction to insure that quality and performance requirements are fulfilled.
Assists Manufacturing, Sourcing and Development in the interpretation and application of regulations.
Develops and maintains department and project budgets.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence
Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
Facilitates team efforts on quality engineering projects.
Ability to deliver, meet deadlines and have results orientation.
Able to communicate both orally and in written form to multiple levels of the company.
Understanding of QSR/ISO regulations, design assurance and FMEA.
Knowledge of statistics, process control, and process capability
Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
Thorough knowledge base of existing Zimmer Biomet products and a basic understanding of competitive products
B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ)
6+ years' of total engineering experience
4+ years' experience in Engineering focused in one of the following areas, Quality, Quality Assurance, Manufacturing, Development, Regulatory or Compliance
4+ years' FDA regulated industry experience preferred.
Combination of education and experience may be considered (in evaluating experience relative to requirements)
Up to 20%